Controlled Substances Regulations (SOR/2025-242)

Documents

Information

Marginal note:Substances ordered and received

111 A pharmacist who orders a controlled substance or a pharmacist or pharmacy technician who receives a controlled substance, other than one that has been previously returned by an individual or particular person for the purposes of destruction, must record the following information:

• (a) their name;

• (b) with respect to the person from whom the controlled substance is ordered or received, their name and, if applicable, title, as well as their municipal address;

• (c) the date of the order or receipt;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (e) in the case of a finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Substances sold — persons other than individuals

112 A pharmacist who sells or provides a controlled substance to a person, other than an individual referred to in section 113, must record the following information:

• (a) the pharmacist’s name;

• (b) with respect to the person, their name and, if applicable, title, as well as their municipal address;

• (c) the date of the sale or provision;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;

• (e) in the case of a finished product,

  • (i) subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,

  • (iii) subject to subparagraph (iv), its drug identification number, if any, and

  • (iv) if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers; and

• (f) if applicable, the reason for the emergency sale or provision.

Marginal note:Finished product sold — individuals

113 A pharmacist who sells or provides a finished product to an individual for their own use, for the use of another individual or for an animal must record the following information:

• (a) the pharmacist’s name;

• (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;

• (c) the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;

• (d) the number assigned to the prescription;

• (e) the date of the sale or provision;

• (f) with respect to the finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any; and

• (g) if applicable, the number of times that the prescription may be refilled and, if specified, the intervals between refills.

Marginal note:Finished products compounded

114 A pharmacist or pharmacy technician who compounds a finished product must record the following information:

• (a) their name;

• (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal;

• (c) the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise;

• (d) the number assigned to the prescription;

• (e) the date of compounding the finished product; and

• (f) with respect to the finished product,

  • (i) its name, and

  • (ii) its form, strength, the number of containers and, if applicable, the number of units per container.

Marginal note:Controlled substance substitutions

115 A pharmacist who substitutes a controlled substance for another controlled substance identified in a prescription must record the following information:

• (a) their name;

• (b) the number assigned to the original prescription;

• (c) the date of the substitution;

• (d) the name of the controlled substance identified in the prescription; and

• (e) the name of the substitute controlled substance.

Marginal note:Written orders and prescriptions

116 A pharmacist or pharmacy technician who receives a written order for a controlled substance or a written prescription from a practitioner must record the following information:

• (a) the pharmacist’s or pharmacy technician’s name; and

• (b) the date of the order or prescription and the date on which it was received.

Marginal note:Verbal orders and prescriptions

117 A pharmacist or pharmacy technician who receives a verbal order for a controlled substance or a verbal prescription must record the following information:

• (a) their name;

• (b) with respect to the person placing the order or issuing the prescription,

  • (i) in the case of an order from another pharmacist,

    • (A) their name and the name and municipal address of the place where they practise, and

    • (B) a declaration from the other pharmacist that they require the controlled substance for emergency purposes,

  • (ii) in the case of a prescription or order from a practitioner,

    • (A) their name and the name and municipal address of the place where they practise, and

    • (B) if it is an order, a declaration from the practitioner that they require the controlled substance for emergency purposes, or

  • (iii) in the case of an order from a hospital,

    • (A) its name and municipal address, as well as the name of the person permitted to place the order on its behalf, and

    • (B) a declaration from that person that the hospital requires the controlled substance for emergency purposes;

• (c) the date of receipt of the order or prescription;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity;

• (e) in the case of a finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any; and

• (f) if applicable, the number of refills authorized in the prescription and, if specified, the interval between refills.

Marginal note:Prescriptions refilled and extended

118 A pharmacist who refills or extends a prescription must record the following information:

• (a) their name;

• (b) the number assigned to the original prescription;

• (c) the date of the prescription refill or extension; and

• (d) if applicable, the new expiration date of the extended prescription.

Marginal note:Prescription transfers — transferring pharmacist

• 119 (1) A pharmacist or pharmacy technician who transfers a prescription to another pharmacist or pharmacy technician must record the following information:

  • (a) their name;

  • (b) with respect to the other pharmacist or pharmacy technician, their name and the name and municipal address of the place where they practise;

  • (c) the number assigned to the prescription;

  • (d) the date of the prescription transfer;

  • (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and

  • (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

• Marginal note:Prescription transfer — receiving pharmacist

  (2) The pharmacist or pharmacy technician who receives the transferred prescription must record the following information:

  • (a) their name;

  • (b) with respect to the pharmacist or pharmacy technician from whom they receive the transferred prescription, their name and the name and municipal address of the place where they practise;

  • (c) the number assigned to the prescription;

  • (d) the date of receipt of the prescription;

  • (e) the date of the last refill of the prescription and, if applicable, the number of authorized refills remaining and, if specified, the interval between refills; and

  • (f) if applicable, the date of the prescription extension and the new expiration date of the extended prescription.

Marginal note:Transportation

120 A pharmacist or pharmacy technician who delivers, sends or transports a controlled substance must record the following information:

• (a) their name and the name and municipal address of the place where they practise;

• (b) if an agent or mandatary of the pharmacist delivers, sends or transports the controlled substance, their name;

• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:

  • (i) if it is not a person referred to in subparagraph (ii), their name and, if applicable, title, or

  • (ii) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;

• (d) the municipal address of the place where the controlled substance is delivered, sent or transported;

• (e) the date of the delivery, sending or transportation;

• (f) the means of transportation;

• (g) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (h) in the case of a finished product,

  • (i) subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,

  • (iii) subject to subparagraph (iv), its drug identification number, if any, and

  • (iv) if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Marginal note:Destruction

121 A pharmacist or pharmacy technician who destroys a controlled substance must record the following information:

• (a) their name;

• (b) the name of the witness to the destruction;

• (c) the municipal address of the place of destruction;

• (d) the date of destruction;

• (e) the method of destruction;

• (f) in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and

• (g) in the case of a finished product,

  • (i) subject to subparagraph (iv), its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) subject to subparagraph (iv), its form, its strength, the number of containers and, if applicable, the number of units per container,

  • (iii) subject to subparagraph (iv), its drug identification number, if any, and

  • (iv) if the finished product has been previously returned by an individual or particular person for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Recording Information and Retention and Provision of Documents

Marginal note:Method of recording

122 A pharmacist or pharmacy technician who records any information under these Regulations must do so using a method that permits an audit of it to be made at any time.

Marginal note:Documents to retain

• 123 (1) A pharmacist who is responsible for the operations of a pharmacy where the information was recorded under these Regulations or, if a pharmacy ceases its operations, the person who was responsible for those operations on the date those operations ceased must, subject to subsection (2), ensure that

  • (a) any document containing the information that must be recorded under these Regulations is kept for two years after the day on which the last record is recorded in the document;

  • (b) every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received; and

  • (c) every declaration and report is kept for two years after the day on which it is provided or received.

• Marginal note:Substances sold or provided

  (2) All documents regarding the sale or provision of a controlled substance must be kept separately, in sequence as to date and number.

Marginal note:Place

124 The documents must be accessible

• (a) at the pharmacy where the information was recorded; or

• (b) if that pharmacy has ceased its operations, at a place in Canada.

Marginal note:Quality of documents

125 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Marginal note:Providing documents

126 A pharmacist who is responsible for a pharmacy’s operations or, if a pharmacy has ceased its operations, the person who was responsible for those operations on the date those operations ceased must provide any documents that the Minister requests in the time and manner that the Minister specifies.